2. Poison Prevention Packaging Act (PPPA)
The Poison Prevention Packaging Act (PPPA) of 1970 regulates
household substances and requires that they be packaged for
consumer use in Child-Resistant Packaging (C-RP).
C-RP is defined as special packaging that is significantly difficult for
children under the age of five to open. Some of you may be saying,
“I can never get those darn caps off, and I’m an adult!” Well,
interestingly enough, the PPPA also says that not more than 10% of
adults should be unable to open the Child-Resistant container. Are
you part of the 10%?
3. Poison Prevention Packaging Act (PPPA)
Medication Packaging
There are some instances when both prescription & non-prescription
drugs may be exempt from the PPPA’s child-resistant container
specifications.
Patient requests non-compliant packaging
Requests should be made in writing (could possibly be an annotation on
the back of a prescription or a permanent record to be filed).
There are a limited number of prescription drugs that are exempt for
varying reasons. One example is sublingual Nitroglycerin because quick
access to the drug may be needed. Still others may be packaged to help
the consumer comply with directions (e.g., oral contraceptives).
4. There is a new classification of medication brought on
by the Combat Methamphetamine Epidemic Act of 2005
that covers over-the-counter (OTC) Pseudoephedrine
It is now in a class called "Scheduled Listed Chemical
Products" and went into effect March 2006
The term “Scheduled Listed Chemical Product” means:
(1) a product that contains Ephedrine, Pseudoephedrine,
or Phenylpropanolamine; and
(2) may be marketed or distributed lawfully in the
United States under the Federal Food, Drug, and
Cosmetic Act (FDCA) as a non-prescription drug
5. Scheduled Listed Chemical Products
The Combat Methamphetamine Epidemic Act of 2005:
Limits daily retail sales to 3.6 grams per person
Limits 30-day retail purchases to 9 grams per person
Requires non-liquid forms to be sold in blister packs (with
some exceptions)
Requires sellers to place the product behind-the-counter
It also requires sellers to maintain a written or electronic
list “logbook” of sales
6. Prescribers are licensed by their governing bodies
The Food and Drug Administration (FDA) and the Drug
Enforcement Agency (DEA) have no authority in
determining prescribers
Standard practitioners in all 50 states are physicians,
surgeons, doctors of osteopathy, dentists, podiatrists,
veterinarians, and optometrists (Note: Military
pharmacies only accept prescriptions from military
veterinarians and only for military dogs and horses)
7. Schedule I Controlled Substances Schedule IV Controlled Substances
(C-I) Substances in this schedule (C-IV)
have a high potential for abuse, Substances in this schedule have a low
have no currently accepted medical potential for abuse relative to
use in treatment in the U.S., & substances in schedule III. (Examples:
there is a lack of accepted safety (Xanax®, Valium®, and Restoril®)
for use of the drug or other
substance under medical Schedule V Controlled Substances
supervision. (Example: Heroin) (C-V) Substances in this schedule have
Schedule II Controlled Substances a low potential for abuse relative to
(C-II) Substances in this schedule substances listed in schedule IV and
have a high potential for abuse consist primarily of preparations
which may lead to severe containing limited quantities of certain
psychological or physical narcotics. These are generally used for
dependence. (Examples: Ritalin® antitussive, antidiarrheal, and analgesic
and Morphine) purposes. (Example: Robitussin AC®)
Schedule III Controlled Substances
(C-III) Substances in this
schedule have a potential for abuse
less than substances in schedules I
or II, and abuse may lead to
moderate or low physical
dependence or high psychological
dependence. (Example: Vicodin®)
8. C-II Prescriptions have strict guidelines:
◦ No C-II orders may be received orally, by fax, or by e-mail
◦ Faxed C-II orders are in essence ONLY for the purpose of
advising pharmacy personnel the patient is en-route with the
original order
◦ Only original hand-written orders may be dispensed
◦ C-II prescriptions cannot designate refills. If the prescriber
wants the patient to continue the C-II medication, a new
prescription for the drug must be written
Providers who are authorized to prescribe controlled drugs
are given a registration number by the DEA. This registration
or DEA number must be written or embossed on the patient’s
controlled drug prescription/order for that prescription to be
valid.
9. DEA numbers should have two letters and seven digits
…for example, the DEA number AR5472612
To verify the numbers are valid: The second, fourth, and
sixth digits are added and their sum is multiplied by 2
That result is added to the sum of the first, third, and
fifth digits
The last digit of the total of the two sums should equal
the seventh digit of the DEA number
Confused? Let’s break it down…
10. Sample DEA Number AR5472612
The second, fourth, and sixth digits (4 + 2 + 1) add up to 7, and
7 times 2 equals 14.
The first, third, and fifth digits (5 + 7+ 6) add up to 18.
The total of the two sums (14 + 18) is 32.
Finally, if the DEA number is valid, the last digit of the total
(2) is the seventh digit of the DEA number, and the second
letter in the DEA number is the same as the first letter of
the last name of the prescriber.
For example, the second letter in the DEA number below is
an “R”, so your provider’s last name would be something like
Roberts, Ricardo, or Rutabaga.
11. Let’s try one more time…
You receive a prescription at your pharmacy
window. The prescriber is Dr. Lynette K. Watts.
The DEA number written on the prescription is
AW3284065. Is this a good DEA number?
12. AW3284065
2 + 4 + 6 =12 x 2 = 24
3 + 8 + 0 = 11
11 + 24 = 35
The last digit in the calculated sum is 5, which
matches the last digit of the DEA number
The second letter of the DEA number is W matching
the first letter of the prescriber’s last name, Watts
This is a valid DEA number .
13. 0 Food, Drug, and Cosmetic Act 0 Scheduled Listed Chemical Products
0 Durham-Humphrey Amendment 0 Prescribing prescriptions
0 Poison Prevention Packaging Act 0 Controlled substances
0 Verifying DEA numbers
14. Congratulations! You have reached the last slide of the main
lesson. Although all of the information is important, I have set
up a short interactive exercise so the class can ensure that it
understands the formula for DEA numbers. Click on the
interactive DEA numbers link to reach the exercise. After you
have completed the exercise, you are free to attempt the
assessment. Remember, this is only a small piece of a much more
comprehensive law curriculum that an upgraded pharmacy
technician must complete. Furthermore, if you remember from
the initial surveys, this is one course in ten in the complete
curriculum. If you have further interest, I have provided
additional “exploratory links” for any added interest you may have.
Secundum Artem…Gar